Whole-Food Plant-Based Diet to Control Weight and MetaboInflammation in Overweight/Obese Men With Prostate Cancer

NCT05471414 | Active Not Recruiting DMC

• 1 other identifier: 20-07022346
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

Brief Summary

The study is comparing the effect on weight of providing home-delivered whole-food, plant-based meals versus standard, general nutritional counseling to men with prostate cancer on androgen-deprivation therapy (ADT).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in weight from baseline to 4 weeks post-randomization

  All participates will be weighed at the baseline visit and at 4 weeks. A two-sample t-test will be used to compare the average change in weight (baseline weight minus 4-week weight).

  Baseline; 4 weeks post-randomization

Secondary Outcomes (16)

• Change in levels of serum hsCRP from baseline to 4, 8, and 26 weeks post-randomization

  Baseline; 4, 8, and 26 weeks post-randomization

• Change in levels of serum IL-6 from baseline to 4, 8, and 26 weeks post-randomization

  Baseline; 4, 8, and 26 weeks post-randomization

• Change in levels of serum glucose from baseline to 4, 8, and 26 weeks post-randomization

  Baseline; 4, 8, and 26 weeks post-randomization

• Change in levels of serum leptin from baseline to 4, 8, and 26 weeks post-randomization

  Baseline; 4, 8, and 26 weeks post-randomization

• Change in levels of serum adiponectin from baseline to 4, 8, and 26 weeks post-randomization

  Baseline; 4, 8, and 26 weeks post-randomization

Study Arms (2)

Whole-food, Plant-based Diet (WFPBD)

EXPERIMENTAL

Home-delivered WFPBD meals will be provided to participants, along with nutritional coaching and education. 12 meals a week will be delivered for the first 4 weeks, followed by 6 meals a week for the next 4 weeks. Finally, for the last 18 weeks they will not receive pre-packed meals, but will continue to receive WFPBD coaching. 30 participants are anticipated to be accrued in this arm.

Behavioral: Whole-food, Plant-Based Diet

General Nutrition Counseling

ACTIVE COMPARATOR

Participants will receive general nutritional counseling weekly for the first 4 weeks, followed by monthly nutritional counseling for the following 18 weeks. 30 participants are anticipated to be accrued in this arm.

Behavioral: General Nutritional Counseling

Interventions

Whole-food, Plant-Based Diet BEHAVIORAL

Pre-packaged, freshly made plant-based meals (provided by either Plantable or CookUnity) will be delivered weekly to participants' homes for 8 weeks. Meals are made with whole ingredients including whole grains, vegetables, legumes, nuts and seeds. Added sugar, animal-based products, refined grains, and processed foods are not used in any meal. Participants will be coached via phone calls, SMS, emails, and the app throughout the intervention to prepare meals in accordance with the diet. Participants will have access to a Registered Dietitian. During the first 4 weeks, 12 meals/week will be provided to participants; followed by 6 meals/week for the next 4 weeks; followed by 18 weeks where participants will continue to receive coaching, but will be expected to make all their own whole-food, plant-based meals with staff assistance available.

Whole-food, Plant-based Diet (WFPBD)

General Nutritional Counseling BEHAVIORAL

All study participants will receive consult with a Registered Dietitian at the Baseline visit and visit 1 study assessments. After visit 1, study participants assigned to the general nutritional counseling arm will receive an additional in-person or telehealth consultation with a Registered Dietitian that will consist of identification and counseling to improve diet quality and achieve a healthy body weight consistent with American Cancer Society guidelines. Study participants in the control group will continue to receive general nutritional counseling and education with weekly scheduled telephone consultations with a Registered Dietitian for the first 4 weeks of the study period. For the remainder of the study period, they will receive counseling and education from Registered Dietitians via monthly scheduled phone calls.

General Nutrition Counseling

Eligibility Criteria

• Age: 45 Years - 99 Years
• Gender Eligibility Details: Male subjects with a diagnosis of prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Receiving androgen deprivation therapy (ADT) with an LHRH/GnRH analogue (agonist/antagonist); or have undergone bilateral orchiectomy. Patients with localized prostate cancer, non-metastatic castrate resistant prostate cancer (CRPC), metastatic hormone sensitive prostate cancer and metastatic CRPC are all eligible.
• On ADT for at least 24 weeks pre-study with anticipation of at least 26 more weeks of therapy from the date of initiation of the dietary intervention
• Patients receiving an anti-androgen (including, but not limited to drugs such as bicalutamide, abiraterone, enzalutamide or apalutamide) are eligible if they have been on therapy for at least 3 months and plan to continue for the duration of the study
• At least 3 months post completion of chemotherapy and/or radiation
• Bone resorptive agents such as bisphosphanates and denosumab are allowed.
• Testosterone level \<50 ng/dL
• Age ≥ 45 years
• BMI ≥ 27
• ECOG performance status of 0 to 1
• Adequate organ and marrow function, based upon meeting all of the following laboratory criteria:
• White blood cell count ≥ 2500/mm3 (≥ 2.5 GI/L)
• Platelets ≥ 100,000/mm3 (≥ 100 GI/L) without transfusion
• Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≤ 2x ULN (or for subjects with Gilbert's disease direct bilirubin WNL) Note: Subjects with elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (up to 5x ULN) will be eligible if elevation is felt to be due to fatty liver disease related to obesity.

You may not qualify if:

• Insulin-dependent diabetes mellitus
• Nut or legume allergy, gluten intolerance or celiac disease
• Currently consuming a vegetarian or vegan diet
• Concurrent participation in other nutrition or weight loss programs
• Expected changes in chronic medications, including statins or oral diabetes medication during the study period (including a change in medication dosage)
• Expected radiation, chemotherapy, bone resorptive agents or anti-androgen within 2 months of beginning the diet intervention
• Expected changes in exercise patterns during the study period
• Psychiatric illnesses or social situations that would limit compliance with study requirements, including a living situation that does not allow for the delivery of Plantable prepared meals, or the inability or lack of equipment to perform basic cooking tasks
• Known history of electrolyte imbalance or micronutrient deficiency, e.g., magnesium, cobalamin
• Ongoing use of warfarin anticoagulants
• Diagnosed, active inflammatory bowel disease
• Inability to receive Emails or have a smart phone

Sponsors & Collaborators

• Plantable Inc.: collaborator
• Prostate Cancer Foundation: collaborator
• CookUnity: collaborator
• Weill Medical College of Cornell University: lead

Study Sites (3)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21231, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• David M Nanus, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 22, 2022
• Study Start: September 22, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)